Pfizer's dacomitinib misses in NSCLC trials

Pfizer Inc. (NYSE:PFE) reported data on Monday from two double-blind, international Phase III trials evaluating once-daily oral dacomitinib ( PF-00299804) to treat advanced non-small cell lung cancer (NSCLC). In the ARCHER 1009 trial, dacomitinib missed the co-primary endpoints of improving progression-free survival (PFS) vs. Tarceva erlotinib in all NSCLC patients and in patients with wild-type K-Ras NSCLC. The trial enrolled about 800 patients with advanced NSCLC previously treated with one or more chemotherapy regimens. In the NCIC CTG BR.26 trial, dacomitinib missed the primary endpoint of improving overall survival (OS) vs. placebo. The trial enrolled about 720 patients with locally advanced or metastatic NSCLC previously treated with one or more chemotherapy regimens and an EGFR inhibitor treatment regimen. Pfizer said it is analyzing the data from the trials to better understand the effects of dacomitinib in molecularly defined subgroups of patients with advanced NSCLC, including patients with EGFR mutations.

Data from the Phase III ARCHER 1050 trial evaluating dacomitinib vs. Iressa gefitinib as first-line treatment of EGFR-mutant advanced NSCLC are expected in 2015. SFJ Pharmaceuticals Inc. (Pleasanton, Calif.) is funding and conducting the trial in exchange for potential milestones and royalties tied to sales of the inhibitor of human EGFR1, EGFR2 and EGFR4 in first-line NSCLC (see BioCentury Extra, Sept. 7, 2012). ...